Cleared Traditional

MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS

K133344 · Sebia · Chemistry
Mar 2014
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K133344 is an FDA 510(k) clearance for the MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on March 28, 2014, 149 days after receiving the submission on October 30, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K133344 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2013
Decision Date March 28, 2014
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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